The Olympus Optical Co.
Medical device manufacturer in Melville, NY.
48510(k) clearances
0PMA approvals
0recalls
Device types
- LFL Instrument, Ultrasonic Surgical 5
- GEI Electrosurgical, Cutting & Coagulation &… 4
- FDS Gastroscope And Accessories, Flexible/Rigid 4
- EOQ Bronchoscope (Flexible Or Rigid) 4
- ODG Endoscopic Ultrasound System… 3
- ITX Transducer, Ultrasonic, Diagnostic 3
- EOB Nasopharyngoscope (Flexible Or Rigid) 3
- ODA Endoscopic Central Control Unit 2
- GWG Endoscope, Neurological 2
- FDF Colonoscope And Accessories, Flexible/Rigid 2
- LBK Neurosurgical Ultrasonic Instruments 1
- FCL Forceps, Biopsy, Non-Electric 1
- HIF Insufflator, Laparoscopic 1
- PSV Ultrasound Bronchoscope 1
- GCJ Laparoscope, General & Plastic Surgery 1
- OCZ Endoscopic Grasping/Cutting Instrument… 1
- FBK Endoscopic Injection Needle… 1
- ODD Endoscopic Retrograde Cholangiopancreatograp… 1
- FAJ Cystoscope And Accessories, Flexible/Rigid 1
- PKL Hemostatic Metal Clip For The Gi Tract 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K033225 | Evis Exera Bronchofibervideoscope Olympus BF Type XP160F, Its Accessories and Ancillary…EOQ · Traditional | 10/16/2003SE |
| K032066 | Sonosurg SystemLFL · Traditional | 10/03/2003SE |
| K031305 | Olympus Ultrasonic Surgical SystemLFL · Traditional | 09/23/2003SE |
| K031648 | Visera Rhino-Laryngovideoscope Olympus Enf Type VEOB · Traditional | 07/24/2003SE |
| K032092 | Olympus XCYF-TP3 Cystofiberscope/NephrofiberscopeFCL · Traditional | 07/16/2003SE |
| K031347 | Ultrasonic Gastrovideoscope, Type UC160P-AT8 and UCT160-AT8ODG · Traditional | 05/09/2003SE |
| K030194 | XUES-41 Endoscopic Electrosurgical UnitKNS · Traditional | 03/24/2003SE |
| K024138 | Heat Scissors Generator Set and Heat Scissors HandpieceGEI · Traditional | 03/12/2003SE |
| K021962 | Olympus Ultrasonic Surgical SystemLFL · Traditional | 02/12/2003SE |
| K021852 | Olympus PSD-20 Electrosurgical System & Its Associated AccessoriesGEI · Traditional | 02/11/2003SE |
| K023984 | Modification to Olympus Bronchoscopes BF-40 Series, BF-240 Series, and BF-160 SeriesEOQ · Traditional | 01/31/2003SE |
| K022445 | Visera Hysterovideoscope Olympus Hyf Type VHIH · Traditional | 01/24/2003SE |
| K023272 | Disposable Aspiration Needle NA-200HFCG · Traditional | 12/23/2002SE |
| K024033 | XTJF-160AF DuodenovideoscopeFDT · Traditional | 12/20/2002SE |
| K023280 | Olympus PSD-20 Electrosurgical System and Its Associated AccessoriesGEI · Traditional | 12/19/2002SE |
| K023767 | UES-30 Electrosurgical Unit and It's Associated AccessoriesGEI · Special | 11/29/2002SE |
| K013759 | MSS-28CS-301/701 NeedlescopeGWG · Traditional | 08/20/2002SE |
| K022270 | Modification to Olympus Integrated Endosurgery System EndoalphaODA · Special | 08/14/2002SE |
| K021179 | Disposable Guidewire, Models G-205-3545S & G-205-3545AOCY · Traditional | 07/05/2002SE |
| K014166 | UHI-3 High Flow Insufflation UnitHIF · Traditional | 06/25/2002SE |
| K021886 | Olympus Ultrasonic Gastrovideoscope GF Type UC140P-DO5 & Olympus Ultrasonic…FDS · Traditional | 06/19/2002SE |
| K021204 | Olympus BF Type UM40PSV · Traditional | 05/01/2002SE |
| K013617 | LTF-240 Pleuravideoscope, Its Accessories and Ancillary EquipmentsGCJ · Traditional | 01/30/2002SE |
| K013591 | Xenf-Tp Rhino-Laryngofiberscope, Its Acessories and Ancillary EquipmentEOB · Traditional | 12/26/2001SE |
| K012074 | XBO1-824-18/19/20 Biopsy ForcepsOCZ · Traditional | 09/25/2001SE |
| K012073 | Olympus Spray Catheter PW-6C-1EOQ · Traditional | 08/10/2001SE |
| K011484 | Olympus Injector NM-4-1, NM-5-1, NM-6-1, NM-7-1, NM-8-1, NM-9-1FBK · Traditional | 08/10/2001SE |
| K011869 | Xenf-Dp Rhino-Laryngofiberscope, Its Accessories and Ancillary EquipmentEOB · Traditional | 07/25/2001SE |
| K011151 | Evis Exera Gastrointestinal Videoscope GIF-Q160ZFDS · Special | 05/15/2001SE |
| K011149 | Disposable Bending Cannula PR-233QODD · Special | 05/15/2001SE |
| K010591 | Olympus EU-C60 Eus Exera Compact Endoscopic Ultrasound CenterODG · Traditional | 03/15/2001SE |
| K002231 | Lf-Dp Gastrointestinal and Sigmoid Fiberscope, Accessories and Ancillary EquipmentFDS · Traditional | 01/30/2001SE |
| K002749 | Endoscope Contour Detection Device, Model 3DX45 and Colonoscope, Model XCF-Q140L/13DFDF · Traditional | 12/04/2000SE |
| K000095 | Olympus Sonosurg Trocar XT3900 SystemLFL · Traditional | 09/26/2000SE |
| K001766 | Olympus XGIF-N200H Gastrointestinal VideoscopeFDS · Traditional | 09/08/2000SE |
| K001203 | Olympus Um 2R/3R Ultrasonic Probe and Associated Ancillary Equipment for Female…ITX · Traditional | 05/26/2000SE |
| K001241 | Evis Exera Colonovideoscope CF-Q160 Al/I and PCF-160 Al/IFDF · Special | 05/09/2000SE |
| K993041 | Olympus XCYF-1T3 Oes Cystofiberscope/Nephrofiberscope Accessories and Ancillary EquipmentFAJ · Traditional | 03/30/2000SE |
| K990687 | HX-5/6-1 Endoscopic Clipping Device, Endoscopic ClipsPKL · Traditional | 03/26/1999SE |
| K982610 | Olympus UM-2R/3R Ultrasonic Probes and Associated Ancillary Equipment (Urinary Tract)ITX · Traditional | 11/16/1998SE |
| K982733 | Olympus MH-246R Balloon Sheath, for Bronchial UseITX · Traditional | 10/28/1998SE |
| K982133 | Olympus Endoscopic System Lumbar Hernia Discectomy and Its Ancillary EquipmentHRX · Traditional | 10/22/1998SE |
| K982734 | Olympus MH-246R Balloon Sheath, for Urinary Tract UseODG · Traditional | 10/05/1998SE |
| K981993 | Olympus Integrated Endosurgery System EndoalphaODA · Traditional | 08/21/1998SE |
| K971340 | Olympus Neuro EndoscopeGWG · Traditional | 07/29/1998SE |
| K981543 | Olympus Lf-Tp and Lf-Dp Tracheal Intubation Fiberscopes, Accessories and Ancillary…EOQ · Traditional | 06/08/1998SE |
| K972114 | Olympus Sonosurg SystemLFL · Traditional | 05/18/1998SE |
| K962952 | Olympus Ultrasonic Surgical System (Usu)LBK · Traditional | 11/29/1996SE |